BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA ULTRA UNIVERSAL

    MDR report key: 2110297 · Received May 26, 2011

    Report

    Report Number
    2110297
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 23, 2011
    Manufacturer
    COVIDIEN
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE SURGEON FIRED THE ENDO GIA STAPLER WITH A WHITE LOAD ACROSS THE BASE OF THE APPENDIX. AFTER THEY PLACED THE APPENDIX INTO THE ENDOCATCH AND BROUGHT IT OUT THROUGH THE 12MM TROCAR SITE, THEY REINTRODUCED THE TROCAR AND INSPECTED THE STAPLE LINE. THEY SAW THAT THE STAPLER DID NOT FIRE APPROPRIATELY IN THE MID PORTION OF THE STAPLE LINE. THE AREA HAD TO BE OVER SEWN WHICH INCREASED THE TIME IN THE OR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDO GIA ULTRA UNIVERSAL STAPLER, SURGICAL GDW COVIDIEN EGIAUSTND NID0288 UK

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR